Innovate’s highly experienced and broad knowledge team of medical writers work on a variety of projects from initial protocol development to clinical study reports and final regulatory documentation. Our medical writers will ensure clear written and high quality communications with sites, investigators and concerned regulatory agencies throughout the product development and commercial process.
Comprised of scientists, many with advanced degrees, Innovate Research medical writing team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development.
They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines, Schedule Y and ICMR or any other guidelines if required.
- Protocols and protocol amendments
- Informed Consent Forms/Patient Information Leaflets
- Clinical study reports
- Subject narratives
- Investigator Brochures
- Integrated summaries of safety/efficacy
- Literature summaries
- Clinical expert reports
- INDs, NDAs summary documents
- IND and NDA Annual reports
- Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs)
- Clinical trial registry synopses
- Symposia publications
- Slide presentations
- Publication plans